SYDNEY and BEDMINSTER, N.J., July 18, 2011 /PRNewswire/
— QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today
initiation of the New Drug Application (NDA) approval process for
MoxDuo IR with the United States Food and Drug Administration
(FDA). This NDA submission sets the stage for the regulatory
approval process for MoxDuo IR for the treatment of moderate to
severe acute pain, a $2.5 billion segment of the $8 billion spent
annually on prescription opioids in the US. MoxDuo IR, an
immediate-release Dual Opioid® pain therapy, is a patented 3:2
fixed ratio combination of morphine and oxycodone.
“In just four years, we have successfully moved MoxDuo IR
through clinical trials and NDA submission by demonstrating its
effectiveness and safety. Achievement of this milestone clearly
establishes the value of this Dual Opioid product to patients and
prescribers as well as potential partners,” said Dr. John Holaday,
Managing Director and Chief Executive Officer, QRxPharma. “The
timeframe and capital efficient manner in which these milestones
were achieved are impressive accomplishments compared to
conventional industry development and cost benchmarks.”
This NDA submission is based on a full clinical and
manufacturing program for MoxDuo IR. As agreed with the FDA, the
NDA for MoxDuo IR is being submitted under 505(b)(2) regulations
wherein approval for a new drug may be obtained more efficiently
because the approval process can rely upon historical data
regarding its’ already approved components. A 505(b)(2) approval
also provides commercial benefits because, in parallel to patents
which cover MoxDuo until 2029, it affords to the sponsor additional
regulatory market exclusivity, allowing companies to develop a
marketing strategy with a brand consumers recognize and may prefer
in a potentially wide-open market.
As agreed with the FDA during its pre-NDA meeting with the
Company in March, 2011, the NDA manufacturing section fil
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